Correvio Pharma has resubmitted a New Drug Application (NDA) to the US FDA seeking approval for Brinavess (vernakalant hydrochloride, IV), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).
Tesaro has submitted a supplemental New Drug Application (sNDA) to the FDA for Zejula (niraparib). The application was granted priority review and has an action date of 24 October 2019.
Dova Pharmaceuticals, Inc announced that the European Commission (EC) has granted marketing authorization for Doptelet (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.
Pacira BioSciences, Inc. announced that the company’s Marketing Authorization Application (MAA) for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia was validated by the European Medicines Agency (EMA).
Dr Popat gives an update of the ongoing studies in mesothelioma in the UK
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